Atopic DermatitisPhase 4NCT03050294
Evaluating Treatment Resistant Dermatitis TaroIIR
A Phase 4 study testing Phone calls and Desoximetasone 0.25% spray in people with Atopic Dermatitis and Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment of both these conditions, especially when they are localized rather than wide spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis, Psoriasis
- What is being tested?
- Phone calls and Desoximetasone 0.25% spray
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 Jun 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age at baseline visit.
- Documentation of plaque-type psoriasis or atopic dermatitis diagnosis as evidenced by one or more clinical features
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- No access to a phone throughout the day
- Subject is diagnosed with a disease that is known to effect adherence and would otherwise bias our results (Such as Alzheimer's or dementia)
- Patient had a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157
About this study
Official title: Study to Evaluate Resistant Disease/Max Adherence to Topical Treatments in Patients With Atopic Dermatitis and Psoriasis
Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment of both these conditions, especially when they are localized rather than wide spread. The development of resistance to treatment is termed tachyphylaxis. Poor adherence, rather than down regulation of receptors, may be the primary cause of tachyphylaxis to topical corticosteroids. The primary objective of the study is to determine, under conditions designed to assure good adherence, whether topical 0.25% desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory skin disease defined by failure of previous topical steroid treatment.
Read the detailed description
Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment of both these conditions, especially when they are localized rather than wide spread. Prolonged treatment with corticosteroids occasionally results in resistance to treatment. The development of resistance to treatment is termed tachyphylaxis. Tachyphylaxis has been thought to be a result of down regulation of target receptors, resulting is a decreased metabolic effect of the compound.
Poor adherence, rather than down regulation of receptors, may be the primary cause of tachyphylaxis to topical corticosteroids. Patients' use of topical medications decrease over time. Topical spray vehicles have become increasingly more popular because of their rapid application and ease of use. Desoximetasone 0.25% spray is a well-tolerated, FDA approved, potent topical corticosteroid that rapidly and successfully treats inflammatory skin diseases.
Lots of treatment options exist for psoriasis; however, some patients do not get better using these medications. These patients are said to have resistant disease. In this study, we define resistant disease by failure of previous topical steroid treatment. Poor adherence is a barrier to positive clinical outcomes. Failure to respond to medication may be a result of poor adherence rather than resistance to the topical therapy. The purpose of this study is to delineate between the two.
The primary objective of the study is to determine, under conditions designed to assure good adherence, whether topical 0.25% desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory skin disease defined by failure of previous topical steroid treatment.
We propose to enroll 12 subjects with psoriasis and 12 subjects with atopic dermatitis who have "failed" previous topical treatment. Subjects will be required to have body surface area involvement that can be reasonably treated with topical treatment. At the baseline visit, patients will be given Topicort spray and will be shown how to use it. Patients will apply the medication at the initial visit under supervision. Subjects with atopic dermatitis will be treated for 1 week; subjects with psoriasis will be treated for 2 weeks. Visits will take place at baseline, 3 days, 1 week, and in the case of psoriasis, 2 weeks. All subjects enrolled in the study will receive nominal compensation per visit.
To assure good adherence to treatment, patients will be called twice each day, morning and evening, at predetermined times to go over their use of the medication. Disease severity will be measured by EASI (atopic dermatitis)/PASI (psoriasis), Investigator Global Assessment (IGA), and Pruritus Visual Analog Scale (Pruritus VAS). Based on our previous experience, we expect rapid improvement in disease severity measures with good adherence to short term use of highly effective topical treatment. Mean and median changes in the efficacy measures will be reported. In the primary analyses, Wilcoxon signed rank tests will be used to analyze improvements in assessments at end of study compared to baseline.
- Conditions
- Atopic Dermatitis, Psoriasis
- Being tested
- Phone calls, Desoximetasone 0.25% spray
- Medical subject headings
- Dermatitis, Atopic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callsBehavioural
Phone calls twice daily
Desoximetasone 0.25% sprayDrug
Desoximetasone 0.25% spray applied twice daily
| Study group | Role | What they receive |
|---|---|---|
| Control- Atopic Dermatitis | Active comparator | Participants with atopic dermatitis will receive desoximetasone and no calls. Receives: Drug: Desoximetasone 0.25% spray |
| Atopic Dermatitis Intervention | Experimental | Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication. Receives: Behavioral: Phone calls; Drug: Desoximetasone 0.25% spray |
| Control- Psoriasis | Active comparator | Participants with psoriasis will receive desoximetasone and no calls. Receives: Drug: Desoximetasone 0.25% spray |
| Psoriasis Intervention | Experimental | Participants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication. Receives: Behavioral: Phone calls; Drug: Desoximetasone 0.25% spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment- Atopic Dermatitis
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
Measured: 1 week
Investigator Global Assessment- Psoriasis
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
Measured: 2 weeks
Secondary outcomes (6)
Total Lesion Severity Score- Atopic Dermatitis
The total lesion severity score measures scaling, erythema, and plaque elevation. The score range is 0-15, with higher scores denoting worse outcomes.
Measured: 1 week
Total Lesion Severity Score-Psoriasis
The total lesion severity score measures scaling, erythema, and plaque elevation. The score range is 0-15, with higher scores denoting worse outcomes.
Measured: 2 weeks
Eczema Area and Severity Index- Atopic Dermatitis
Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.
Measured: 1 week
Pruritus Visual Analog Scale- Atopic Dermatitis
The Pruritus VAS is a scale consisting of a 10cm long line and a single question. The left end point represents "no itch" (score of 0) and the right end point the "worst imaginable itch" (score of 10).
Measured: 1 week
Pruritus Visual Analog Scale- Psoriasis
The Pruritus VAS is a scale consisting of a 10cm long line and a single question. The left end point represents "no itch" (score of 0) and the right end point the "worst imaginable itch" (score of 10).
Measured: 2 weeks
Psoriasis Area and Severity Index
The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected areas (head, arms, trunk, and legs). The severity of three clinical signs (erythema, induration and desquamation) are on a scale from 0 to 4 (from absent to very severe). An area and severity score for each region is calculated by multiplying the area score by the severity score. The score range is 0-72, with higher scores denoting worse outcomes.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start1 Feb 2017
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050294
- Sponsor's protocol ID
- IRB00039302
- Status last verified
- May 2020
- First submitted
- 8 Feb 2017
- Last updated
- 20 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Resistant Disease/Max Adherence to Topical Treatments in Patients With Atopic Dermatitis and Psoriasis
- ClinicalTrials.gov ID
- NCT03050294
- Acronym / sponsor ID
- IRB00039302
- Conditions
- Atopic Dermatitis, Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Posted 15 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment of both these conditions, especially when they are localized rather than wide spread. The development of resistance to treatment is termed tachyphylaxis. Poor adherence, rather than down regulation of receptors, may be the primary cause of tachyphylaxis to topical corticosteroids. The primary objective of the study is to determine, under conditions designed to assure good adherence, whether topical 0.25% desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory skin disease defined by failure of previous topical steroid treatment.
Detailed description
Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment of both these conditions, especially when they are localized rather than wide spread. Prolonged treatment with corticosteroids occasionally results in resistance to treatment. The development of resistance to treatment is termed tachyphylaxis. Tachyphylaxis has been thought to be a result of down regulation of target receptors, resulting is a decreased metabolic effect of the compound.
Poor adherence, rather than down regulation of receptors, may be the primary cause of tachyphylaxis to topical corticosteroids. Patients' use of topical medications decrease over time. Topical spray vehicles have become increasingly more popular because of their rapid application and ease of use. Desoximetasone 0.25% spray is a well-tolerated, FDA approved, potent topical corticosteroid that rapidly and successfully treats inflammatory skin diseases.
Lots of treatment options exist for psoriasis; however, some patients do not get better using these medications. These patients are said to have resistant disease. In this study, we define resistant disease by failure of previous topical steroid treatment. Poor adherence is a barrier to positive clinical outcomes. Failure to respond to medication may be a result of poor adherence rather than resistance to the topical therapy. The purpose of this study is to delineate between the two.
The primary objective of the study is to determine, under conditions designed to assure good adherence, whether topical 0.25% desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory skin disease defined by failure of previous topical steroid treatment.
We propose to enroll 12 subjects with psoriasis and 12 subjects with atopic dermatitis who have "failed" previous topical treatment. Subjects will be required to have body surface area involvement that can be reasonably treated with topical treatment. At the baseline visit, patients will be given Topicort spray and will be shown how to use it. Patients will apply the medication at the initial visit under supervision. Subjects with atopic dermatitis will be treated for 1 week; subjects with psoriasis will be treated for 2 weeks. Visits will take place at baseline, 3 days, 1 week, and in the case of psoriasis, 2 weeks. All subjects enrolled in the study will receive nominal compensation per visit.
To assure good adherence to treatment, patients will be called twice each day, morning and evening, at predetermined times to go over their use of the medication. Disease severity will be measured by EASI (atopic dermatitis)/PASI (psoriasis), Investigator Global Assessment (IGA), and Pruritus Visual Analog Scale (Pruritus VAS). Based on our previous experience, we expect rapid improvement in disease severity measures with good adherence to short term use of highly effective topical treatment. Mean and median changes in the efficacy measures will be reported. In the primary analyses, Wilcoxon signed rank tests will be used to analyze improvements in assessments at end of study compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control- Atopic Dermatitis | Active comparator | Drug: Desoximetasone 0.25% sprayParticipants with atopic dermatitis will receive desoximetasone and no calls. |
| Atopic Dermatitis Intervention | Experimental | Behavioral: Phone calls, Drug: Desoximetasone 0.25% sprayParticipants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication. |
| Control- Psoriasis | Active comparator | Drug: Desoximetasone 0.25% sprayParticipants with psoriasis will receive desoximetasone and no calls. |
| Psoriasis Intervention | Experimental | Behavioral: Phone calls, Drug: Desoximetasone 0.25% sprayParticipants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥18 years of age at baseline visit.
- Documentation of plaque-type psoriasis or atopic dermatitis diagnosis as evidenced by one or more clinical features
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Key exclusion criteria (5 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- No access to a phone throughout the day
- Subject is diagnosed with a disease that is known to effect adherence and would otherwise bias our results (Such as Alzheimer's or dementia)
- Patient had a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone callsPhone calls twice daily | Behavioural | Atopic Dermatitis Intervention, Psoriasis Intervention |
| Desoximetasone 0.25% sprayDesoximetasone 0.25% spray applied twice daily | Drug | Atopic Dermatitis Intervention, Control- Atopic Dermatitis, Control- Psoriasis, Psoriasis Intervention |
Primary outcome
Investigator Global Assessment- Atopic Dermatitis
Time frame: 1 week
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
Investigator Global Assessment- Psoriasis
Time frame: 2 weeks
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
6 secondary outcomes
Total Lesion Severity Score- Atopic Dermatitis
Time frame: 1 week
Total Lesion Severity Score-Psoriasis
Time frame: 2 weeks
Eczema Area and Severity Index- Atopic Dermatitis
Time frame: 1 week
Pruritus Visual Analog Scale- Atopic Dermatitis
Time frame: 1 week
Pruritus Visual Analog Scale- Psoriasis
Time frame: 2 weeks
Psoriasis Area and Severity Index
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phone calls and Desoximetasone 0.25% spray in people with Atopic Dermatitis and Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Assessment- Atopic Dermatitis (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.